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In this section, example analysis datasets are shown for the following endpoints:
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- Percent change in ejection fraction
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- for a period of 1 year
- Decline in ejection fraction
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- for a
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- period of 1 year, grouped by a decline greater than 10.0%
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- Percent change in NTproBNP
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- for a period of
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- 1 year
Source Data
The SDTM examples used as the source data are from Section 2.1, Basic CMR Tests - Systolic Function. The CV dataset contains 16 rows, 1-8 for visit 1 and 9-16 for visit 6. Of these rows, the ones where CVTESTCD = "LVEF_C" and "RVEF_C" were used for analysis. In the LB dataset, the records where LBTESTCD = "BNPPRONT" were used to compute the percentage change over time, then added as a potential covariate in each row for the last analysis. The SDTM datasets were merged with a Subject Level Analysis Dataset (ADSL) dataset to record the demographics, treatments and other appropriate variables for analysis.
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